Last Updated: September 24, 2026

Details for New Drug Application (NDA): 064201

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NDA 064201 describes CEFOTAXIME, which is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, and Lupin, and is included in fourteen NDAs. It is available from one supplier. Additional details are available on the CEFOTAXIME profile page.

The generic ingredient in CEFOTAXIME is cefotaxime sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.

Summary for 064201

Tradename:	CEFOTAXIME
Applicant:	Fresenius Kabi Usa
Ingredient:	cefotaxime sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 064201

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Mar 24, 2000	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20GM BASE/VIAL
Approval Date:	Mar 24, 2000	TE:		RLD:	No

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